FDA approves Intuniv

Shire gets US FDA approval for Intuniv, the first selective alpha-2A adrenergic receptor agonist for the treatment of ADHD

Shire has received US Food and Drug Administration (FDA) approval for Intuniv extended release tablets for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years.

Intuniv, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD. Although the mechanism of action is unknown, Intuniv is thought to directly engage receptors found in the prefrontal cortex. Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen the working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioural inhibition and enhance impulse control.

The efficacy of Intuniv in the treatment of ADHD was established in two similarly designed, placebo-controlled clinical trials in children and adolescents aged 6 to 17 years who met Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ADHD. Investigators, parents and teachers reported statistically significant improvements with Intuniv.

Once-daily Intuniv is forecast to be available in US pharmacies in November and will come in four dosage strengths (1mg, 2mg, 3mg and 4mg). It will be marketed in the States by the Shire ADHD team.